Quality Assurance Manager

Cure Talent is working with an innovative digital health start-up developing software-based medical technology for remote patient monitoring and clinical care. As the company continues to develop its technology and strengthen its quality processes, they are looking to appoint a Quality Assurance Manager.

This is a fully remote position for candidates based in the Netherlands, working closely with software engineering, product development and regulatory colleagues.

As the Quality Assurance Manager, you will take ownership of the company's Quality Management System, ensuring quality processes remain practical, effective and aligned with the requirements of a growing medical device business.

Key Responsibilities

• Maintain and continuously improve the company's ISO 13485 Quality Management System.

• Manage document control, CAPA, non-conformances, internal audits and management reviews.

• Work closely with software development teams to ensure quality processes align with IEC 62304 and applicable design control requirements.

• Support risk management activities in accordance with ISO 14971.

• Oversee supplier quality management and qualification activities.

• Support preparation for external audits and Notified Body assessments.

• Develop quality processes that support business growth without introducing unnecessary complexity.

Experience and Skills Required

• Proven Quality Assurance experience within the medical device industry.

• Strong working knowledge of ISO 13485 and medical device quality management systems.

• Experience managing internal audits, CAPA, document control and quality improvement activities.

• Familiarity with IEC 62304 and ISO 14971.

• Experience supporting software-based medical devices or digital health products would be advantageous.

• Strong communication skills and the ability to influence engineering and product development teams.

• Experience working within a start-up or scale-up environment would be beneficial.

This is an opportunity to take ownership of quality activities within a growing digital health company, helping establish scalable processes while supporting the development of innovative medical software.

Interested?

Apply today or contact Cure Talent for a confidential discussion.